introductory medical device prototyping · prof. steven s. saliterman medical device polymers...
TRANSCRIPT
Introductory Medical Device Prototyping
Biomaterials Part 2 – Polymers Prof. Steven S. Saliterman, http://saliterman.umn.edu/ Department of Biomedical Engineering, University of Minnesota
Prof. Steven S. Saliterman
Medical Device Polymers Polyolefins
Polyethylene (PE) Polypropylene (PP) Cyclic Olefin Copolymers (COCs) Polyvinyl Chloride (PVC)
Polystyrene/styrenics Polystyrene Poly(acrylonitrile-co-butadiene-co-styrene)
(ABS) Polyacrylate (Acrylic, PMMA) Polycarbonate (PC) Polyurethanes Polyformaldehyde (POM) (Delrin or Acetal)
Polyamides Polyamide (Nylon 6) Poly(hexamethylene adipamide) (Nylon 66) Polyether Block Amide (PEBA)
Polyesters Poly(butylene terephthalate) (PBT)
Poly(ethylene terephthalate) (PET, PETG) High-Temp Thermoplastics
Polysulfone (PSF) Polyimide (PI) (Kapton) Poly(ether ether-ketone) (PEEK)
Fluoropolymers Poly(tetrafluoroethylene) (PTFE) (Teflon),
PVDF, FEP, ePTFE Elastomers
Silicones Thermoplastic elastomers (TPE): TPA
(polyamide TPE), TPC (copolyester TPA), TPO (olefinic TPE), TPS (styrenic TPE), TPU (urethane TPE), and TPV (vulcanized TPE).
Poly-p-xylylene (Parylene) Biopolymers
Polylactic Acid (PLA) Polyglycolic Acid (PGA)
Others – PANI, PPy, PVAC, PEG
Prof. Steven S. Saliterman
FDA Medical Device Categories
Teo, AJT. Polymeric Biomaterials for Medical Implants and Devices. ACS Biomaterials Sci. Eng. 2016, 2, 454−472
Prof. Steven S. Saliterman
Anesthesiology…
Epidural catheters
(Left) Image Courtesy of Rush University Pain Centers. (Right) Image courtesy of Texas Scientific Instruments.
Prof. Steven S. Saliterman
Cardiovascular…
Pacemaker
(Left) Image Courtesy of NIH Medline Plus. (Right) Image courtesy of Medtronic.
Prof. Steven S. Saliterman
Cardiovascular…
Mitral valve annuloplasty vs. prosthesis for stenosis.
(Left) Image Courtesy of Adam Pick, Heart Valve Surgery.com. (Right) Image courtesy of Prof. Peter Anderson.
Prof. Steven S. Saliterman
Cardiovascular…
Abdominal aortic aneurysm graft.
(Left) Image Courtesy of NIH Medline Plus (Center & Right) Images courtesy of Medtronic
Prof. Steven S. Saliterman
Catheters
Applications for Arkema Pebax® MED include catheters (angioplasty, stent-delivery, diagnostic, ablation…), balloons, tubes (peristaltic pumps, connecting tubes, colonoscopes, hearing aids…) and small-dimension molded parts.
Image courtesy of Arkema
Cardiovascular…
Prof. Steven S. Saliterman
Polyether Block Amide (PEBA)… Copolymer of polyamide and polyethylene
Image courtesy of RSC Advances
Nylon 12 Variable
Prof. Steven S. Saliterman Images courtesy Boston Scientific.
The WATCHMAN® LAAC Device is a catheter-delivered heart implant designed to close the left
atrial appendage (LAA). PET knit fabric mesh.
Access sheath is made from Polytetrafluoroethylene (PTFE)
(Teflon)
Cardiovascular…
Prof. Steven S. Saliterman
Scalpel LNP Lubricomp ® is a 30% carbon fiber reinforced
polycarbonate resin from SABIC for replacing metal in scalpels and other components.
Image courtesy of SABIC
General and Plastic Surgery…
Prof. Steven S. Saliterman
Poly(bisphenol A carbonate) (Polycarbonate) Amorphous highly transparent thermoplastic with properties of high
impact strength, low moisture adsorption, good heat resistance, good rigidity and electrical properties, and high creep.
PC is a good low frequency and high voltage insulator, making it suitable for electrical and electronic components.
PCs are graded by addition of various amounts of glass fibers. These increases tensile strength, stiffness, compressive strength, and lowers the thermal expansion coefficient.
Prof. Steven S. Saliterman
General and Plastic Surgery…
Craniofacial implants made from PEEK polymers with EOS' laser sintering process. Implants with patient-specific size and shape can be manufactured,
based on three-dimensional imaging techniques like computed tomography (CT) and magnetic resonance tomography (MRT).
Image Courtesy of SME.org
Prof. Steven S. Saliterman
Poly(ether ether-ketone) (PEEK) Semi-crystalline thermoplastic with excellent chemical resistance,
very low moisture absorption, and is unaffected by continuous hot steam or water
Graded based on its filler. Unfilled PEEK is light brown or black and is FDA approved for contact with food. Glass filled (30%) PEEK reduces expansion and increases the flexural modulus.
Image courtesy of Invibio.
Prof. Steven S. Saliterman
Parker’s disposable silicone laryngeal mask device. 100% medical-grade silicone device enables easy
insertion and is designed to produce an effective seal.
Image courtesy of Parker.
General and Plastic Surgery…
Prof. Steven S. Saliterman
Poly(dimethyl siloxane) and Trimethylsilyloxy end-blocked polydimethylsiloxanes. Silicones have excellent biocompatibility and biodurability. Flexible with lower tensile strength or tear resistance compared to
polyurethanes. Degrade in strongly acidic or basic environments. Like all hydrophobic materials they become quickly coated with proteins when
placed in tissue contact. Silicone gels are used for breast, testicular and other soft tissue implants. Silicone adhesives are used in bonding and soft skin adhesives to the skin.
Prof. Steven S. Saliterman
Ear, Nose and Throat…
Ototronix Maxum implant in situ on ossicular chain.
Images Courtesy of Ototronix, D. L. Beck and M. Glasscock
Prof. Steven S. Saliterman Teo, AJT. Polymeric Biomaterials for Medical Implants and Devices. ACS Biomaterials Sci. Eng. 2016, 2, 454−472
Prof. Steven S. Saliterman
Urology…
Indwelling Foley catheter.
(Left) Image Courtesy of WebMD (Right) Images courtesy of Poiesis Medical.
Prof. Steven S. Saliterman
Hematology…
Pulmonary artery catheter
Image courtesy of Life in the Fast lane
Prof. Steven S. Saliterman Teo, AJT. Polymeric Biomaterials for Medical Implants and Devices. ACS Biomaterials Sci. Eng. 2016, 2, 454−472
Prof. Steven S. Saliterman
Obstetrics and Gynecology…
Intrauterine device for contraception.
(Left) From Wikimedia Commons. (Right) Bioceptive IUD inserter.
Prof. Steven S. Saliterman
Orthopedic…
The Taylor Spatial Frame is an external fixator used to treat complex fractures and bone deformities
From Wikimedia Commons
Prof. Steven S. Saliterman
Forchelet, D.; Simoncini, M.; Arami, A.; Bertsch, A.; Meurville, E.; Aminian, K.; Ryser, P.; Renaud, P. Enclosed Electronic System for Force Measurements in Knee Implants. Sensors 2014, 14 (8), 15009− 15021.
Knee implant study device with stain gages made from UHMWPE.
Orthopedic…
Prof. Steven S. Saliterman
Polyethylene (PE) Semi-crystalline material with good resistance to organic
solvents, degreasing agents, and electrolytes. It is resistance to wear, fatigue, and staining; and has low
moisture absorption. PE is nontoxic and floats on water. Graded as low density (LDPE), high density (HDPE) and ultra-
high molecular weight (UHMWPE). The latter are self-lubricating, shatter resistance, machinable, and may be sterilized in steam
Boedeker Plastics Inc., 2004
Prof. Steven S. Saliterman
Intraoperative wrench tool ABS-M30i works with 3D FDM Technology to build functional prototypes, tooling
and production parts that can be gamma or EtO sterilized.
Image courtesy of Stratasys
Orthopedic…
Prof. Steven S. Saliterman
Poly(acrylonitrile-co-butadiene-co-styrene) (ABS) ABD is strong & light weight.
Prof. Steven S. Saliterman
Summary
FDA Medical Device Categories Anesthesiology Cardiovascular Dental Ear, Nose & Throat Gastroenterology & Urology General and Plastic Surgery Hematology & pathology Obstetrics and Gynecology Ophthalmology Orthopedics